MAUDE Adverse Event Report: AESCULAP, INC. ANDREWS PYNCHON SUCTION TUBE; CATHETER AND TIP, SUCTION

Model Number MD613

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/04/2015

Event Type  Death  

Event Description

Difficulty obtaining end tidal co2 while attempting to place trach.Cpr initiated, patient reintubated with trach placement, stabilized and ventilated well.Chest x-ray showed piece of suction device noted to be missing after intubation.Patient became hemodynamically unstable, cpr initiated, unable to ventilate through trach tube; it was exchanged with extra long trach tube for better ventilation.Patient transferred to cardiac intensive care.

• Brand Name: ANDREWS PYNCHON SUCTION TUBE
• Type of Device: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 4787079
• MDR Text Key: 5803387
• Report Number: 4787079
• Device Sequence Number: 1
• Product Code: JOL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/08/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD613
• Device Catalogue Number: MD613
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: YES.
• Patient Outcome(s): Death